Comparison of Biocartis IDYLLA ™ cartridge assay with Qiagen GeneReader NGS for detection of targetable mutations in EGFR, KRAS/NRAS, and BRAF genes

Haiduk, Tiffany; Brockmann, Michael; Tillmann, Ramona Liza; Pieper, Monika; Lüsebrink, Jessica; Schildgen, Verena; Schildgen, Oliver

doi:10.1016/j.yexmp.2021.104634

Cited by 6 publications

(5 citation statements)

References 14 publications

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“…In this study, we examined the clinical performance of the Idylla ™ platform and found that its performance was comparable to that described in previous overseas reports [ 7 , 26 , 27 ]. This formal clinical performance study supports the IVD approval of this test in Japan.…”

Section: Discussionsupporting

confidence: 72%

Performance of Idylla™ RAS-BRAF mutation test for formalin-fixed paraffin-embedded tissues of colorectal cancer

et al. 2022

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Background The Biocartis Idylla™ platform is a fully automated, real-time PCR-based diagnostic system. The Idylla™KRAS and NRAS-BRAF Mutation Tests have been developed for the qualitative detection of mutations in KRAS, NRAS and BRAF genes, facilitating the genomic profiling of patients with colorectal cancer. The aim of the present study was to evaluate clinical performances of these tests in Japan. Methods The RAS and BRAF mutation statuses of 253 formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissues were analyzed using the Investigational Use Only Idylla™KRAS Mutation Test and the Idylla™NRAS-BRAF Mutation Test and an in vitro diagnostics (IVD) kit (MEBGEN RASKET™-B kit). Results The success rate for obtaining a valid mutational data without retest of the Idylla tests was 97.6% (247/253): 111 KRAS mutations (43.8%), 9 NRAS mutations (3.6%), and 36 BRAF V600E mutations (14.2%) were detected using the Idylla tests. Compared with the MEBGEN RASKET-B results, the positive concordance rate was 97.4%, the negative concordance rate was 95.7%, and the overall concordance rate was 95.3% (κ = 0.919, 95% CI 0.871–0.967). The average turnaround time to Idylla™KRAS and NRAS-BRAF Mutation Test was 5.6 working days (range: 3–11 days). Conclusion This result demonstrates a high concordance between the Idylla™KRAS and NRAS-BRAF Mutation Tests and an existing IVD kit. In this manner, the Idylla™ mutation tests were validated for the detection of clinically significant KRAS, NRAS, and BRAF mutations in FFPE samples from colorectal cancer patients.

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Section: Discussionsupporting

confidence: 72%

Performance of Idylla™ RAS-BRAF mutation test for formalin-fixed paraffin-embedded tissues of colorectal cancer

et al. 2022

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“…The good sensitivity and specificity of the rapid detection of EGFR mutations using the Idylla TM system were previously reported in other publications on lung cancer, as well as on other cancers such as melanoma and colorectal cancer [ 17 ]. Similarly, as detailed in the introduction, the concordance of EGFR genotyping has already been reported between the Idylla TM system and NGS [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ] or other techniques [ 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 ]. In our center, we chose to introduce the Idylla TM system rather than another rapid assay, because our main objective was to reduce, at maximum, the result of the EGFR genotyping for clinicians and to reduce the need of DNA extraction being performed daily, not allowing this objective to be achieved.…”

Section: Discussionmentioning

confidence: 61%

“…Studies comparing the Idylla TM system and NGS performance [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ] reported a concordance between the two techniques ranging from 94% to 100%, which is consistent with the 96.7% of concordant results between the Idylla TM system and NGS that we evaluated here, especially because the seven apparent discordant results that we reported were not trues discordant: Five missed mutations were not detected by the Idylla TM system, one missed mutation was assayed in a sample with insufficient tumoral cells, and the last missed mutation was sought in a sample not validated on the Idylla TM system (a bone metastasis).…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have already reported the high concordance (from 94% to 100%) between the Idylla TM system and other methods routinely used for EGFR mutation detection from formalin-fixed paraffin-embedded (FFPE) tissue of human lung cancer (NGS: [ 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 ]; pyrosequencing: [ 23 ]; Therascreen ® EGFR RGQ PCR: [ 24 ]; droplet digital PCR: [ 22 ]; ARMS PCR: [ 25 ]; fragment PCR: [ 26 , 27 ]; multiplex PCR: [ 28 ]; real-time PCR (cobas ® EGFR Mutation Test): [ 29 ]; Sanger sequencing: [ 29 , 30 ]), usually through a retrospective and monocenter study, although sometimes prospective [ 13 , 18 , 28 , 29 , 31 ] and rarely multicentric [ 15 ]. Previous studies have thus evaluated the sensitivity, concordance, and reproducibility between NGS and the alternative technical approaches of EGFR genotyping, but whether the early genotyping of EGFR can initiate more quickly the treatment of patients with NSCLC is not clearly answered in the literature.…”

Section: Introductionmentioning

confidence: 99%

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Contribution of the IdyllaTM System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations

et al. 2021

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Epidermal growth factor receptor (EGFR) genotyping, a critical examen for the treatment decisions of patients with non-small cell lung cancer (NSCLC), is commonly assayed by next-generation sequencing (NGS), but this global approach takes time. To determine whether rapid EGFR genotyping tests by the IdyllaTM system guides earlier therapy decisions, EGFR mutations were assayed by both the IdyllaTM system and NGS in 223 patients with NSCLC in a bicentric prospective study. IdyllaTM demonstrated agreement with the NGS method in 187/194 cases (96.4%) and recovered 20 of the 26 (77%) EGFR mutations detected using NGS. Regarding the seven missed EGFR mutations, five were not detected by the IdyllaTM system, one was assayed in a sample with insufficient tumoral cells, and the last was in a sample not validated by the IdyllaTM system (a bone metastasis). IdyllaTM did not detect any false positives. The average time between EGFR genotyping results from IdyllaTM and the NGS method was 9.2 ± 2.2 working days (wd) (12.6 ± 4.0 calendar days (cd)). Subsequently, based on the IdyllaTM method, the timeframe from tumor sampling to the initiation of EGFR-TKI was 7.7 ± 1.2 wd (11.4 ± 3.1 cd), while it was 20.3 ± 6.7 wd (27.2 ± 8.3 cd) with the NGS method (p < 0.001). We thus demonstrated here that the IdyllaTM system contributes to improving the therapeutic care of patients with NSCLC by the early screening of EGFR mutations.

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“…However, we envision that the increasing interest in rapid workflows and novel testing platforms will soon enable broader adoption of rapid testing paradigms. 11,12 Second, because of variability in patient circumstances (including insurance coverage, the plan-based benefit structure, and financial resources), some patients still experienced a delay between the identification of the EGFR mutation and initiation of osimertinib, particularly patients who required co-pay assistance and enrollment in free drug programs. This suggests that complex external factors continue to pose hurdles to ensuring that all patients receive timely, molecularly informed treatment for their cancer irrespective of their social circumstances.…”

Section: Discussionmentioning

confidence: 99%

Integrated Radiology, Pathology, and Pharmacy Program to Accelerate Access to Osimertinib

Dagogo‐Jack

Manoogian

Jessop

et al. 2023

JCO Oncology Practice

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Comparison of Biocartis IDYLLA ™ cartridge assay with Qiagen GeneReader NGS for detection of targetable mutations in EGFR, KRAS/NRAS, and BRAF genes

Cited by 6 publications

References 14 publications

Performance of Idylla™ RAS-BRAF mutation test for formalin-fixed paraffin-embedded tissues of colorectal cancer

Performance of Idylla™ RAS-BRAF mutation test for formalin-fixed paraffin-embedded tissues of colorectal cancer

Contribution of the IdyllaTM System to Improving the Therapeutic Care of Patients with NSCLC through Early Screening of EGFR Mutations

Integrated Radiology, Pathology, and Pharmacy Program to Accelerate Access to Osimertinib

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